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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Rebreathing, Radionuclide
510(k) Number K850366
Device Name MEDIPART XENON BREATHING KIT MP-OIXM-I
Applicant
Medipart Jerry Alexander
607 Spring Beach Rd.
Cary,  IL  60013
Applicant Contact JERRY A ALEXANDER
Correspondent
Medipart Jerry Alexander
607 Spring Beach Rd.
Cary,  IL  60013
Correspondent Contact JERRY A ALEXANDER
Regulation Number892.1390
Classification Product Code
IYT  
Date Received01/30/1985
Decision Date 04/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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